Concert Pharmaceuticals, Inc. announced the presentation of data from its THRIVE-AA1 Phase 3 clinical trial during the 12(th) World Congress for Hair Research. The presentation highlights THRIVE-AA1 study results evaluating Concert's investigational oral medicine deuruxolitinib (CTP-543) in adult patients with moderate to severe alopecia areata, an autoimmune disorder that results in patchy or complete scalp hair loss. The World Congress presentation includes new analyses from THRIVE--AA1 showing the effect of deuruxolitinib on regrowth of scalp hair based on disease severity and duration of current episode of hair loss.

The data are being presented by Brett King, M.D., Department of Dermatology, Yale University School of Medicine and clinical investigator of THRIVE-AA1. "These new data analyses are important to inform treatment of patients with varying degrees of disease severity and duration of current episode of hair loss. For patients receiving deuruxolitinib in THRIVE-AA1, the data show meaningful and significant improvement in patients with the most severe disease and those with longer duration of current episode.

In THRIVE-AA1, significant improvements in scalp hair regrowth compared to placebo were achieved at 24 weeks for patients taking 8 mg twice-daily and 12 mg twice-daily doses of deuruxolitinib, as previously disclosed in the positive topline results reported by Concert earlier this year. The most common (>=5%) side effects in any dose group were headache, acne, upper respiratory infection, increased creatine kinase levels, COVID-19 infection and nasopharyngitis. Upper respiratory infections were greater in the placebo group than in either of the deuruxolitinib dose groups.

No pulmonary embolisms or deep vein thromboses were observed in the trial. One patient treated with the 8 mg twice-daily dose and one patient treated with the 12 mg twice-daily dose developed herpes zoster (shingles). Serious adverse events were reported in nine patients, with only one patient (in the 8 mg twice-daily dose group) having events (2) that were assessed as possibly related to treatment.

Four patients who reported serious adverse events were in the placebo group.